Skip to main content

Services for Pharmaceutical industry

The pharmaceutical industry is among the most highly regulated sectors. At the same time, these fields are becoming increasingly dependent on digital technologies to deliver effective clinical treatments, enhance diagnostics, develop new products, and improve healthcare services overall.

Companies strive to keep pace with innovation while safeguarding their regulatory integrity. At Deloitte, we help clients implement solutions through a regulatory compliance approach that is data-driven, risk-assessed, and focused on fostering business growth rather than restricting it with additional rules. We assist you in establishing a quality management system and implementing a pharmacovigilance system. Our team includes experts in pharmaceutical regulation, clinical trials, pharmacovigilance, and compliance. We also have specialists in digital therapeutics, their regulation, and market entry.

Our Services

  • Classification of SaMD (Software as a Medical Device)
  • Pre- and post-marketing activities
  • Support with regulatory clinical validation
  • Commercialization and market launch
  • Design and implementation of a Quality Management System (QMS)
  • DiGA
  • Pre- and post-marketing activities
  • Drug development plans
  • Pharmaceutical regulatory strategy
  • Support with clinical trial regulation
  • Due diligence
  • Commercialization and market launch of medicines
  • Design and implementation of Quality Management Systems (QMS)
  • Implementation of digital systems from various quality management providers (Veeva, Generis, etc.)
  • Implementation of Regulatory Information Management (RIM) systems
  • Establishment of a pharmacovigilance system for medicines
  • System assessment and optimization
  • Audit